Global Neuroimmunology Clinical Program Lead

AstraZeneca plc

Cambridge (MA)

On-site

USD 288,000 - 432,000

Full time

5 days ago
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Benefits offered by this job

Short-term incentive bonuses
Equity-based awards
Commissions for sales roles
Qualified retirement programs
Health, dental and vision coverage

Job summary

AstraZeneca plc seeks a Global Clinical Program Lead to own two immune-reset programs in neuroimmunology, from first-in-patient to pivotal stages. You will define strategy, oversee safety, design trials, and manage regulatory interactions with regulators, investigators and patient partners from Cambridge, MA.

You will guide cross-functional teams across Global Project Lead, Regulatory, Patient Safety and Biostatistics to ensure timely delivery of high-impact studies that recalibrate the immune

Qualifications

  • MD or equivalent degree; postgraduate specialty training in neurology or related immune-mediated disease.
  • Board certification in neurology or related specialty; substantial clinical experience at attending/consultant level.
  • 5+ years of clinical drug-development experience in biopharma, with leadership of a clinical program or major studies through key milestones.
  • Hands-on leadership of design, delivery and interpretation of multiple industry-sponsored clinical studies.
  • Experience leading health-authority interactions and contributing clinical content to regulatory submissions.
  • Thorough understanding of full drug development process and biostatistics principles.
  • Experience with FDA/EMA/MHRA/ICH GCP requirements for global clinical studies.
  • Proven ability to lead complex programs and matrixed teams; strong influencing skills.

Responsibilities

  • Define and drive clinical and scientific strategy across two programs, including benefit/risk and Clinical Development Plan.
  • Lead endpoint strategy and trial design; ensure studies meet GCP with clear operational plans.
  • Oversee program safety strategy and safety oversight at committees and IDMC/DMC.
  • Own clinical content for IND/CTA submissions and lead health-authority interactions.
  • Present data-driven updates to governance and portfolio committees; align with Global Clinical Head on strategy and investments.
  • Build external partnerships with investigators, sites, CROs and patient groups to shape plans.
  • Provide matrix leadership to study physicians and clinical scientists across functions.
  • Monitor advances in neuroimmunology and translate data into differentiated clinical plans.

Skills

Clinical program leadership
Regulatory interactions
Cross-functional leadership
Global drug development
Stakeholder communication

Education

MD or equivalent + PhD
Neurology specialty board certification

Job description

AstraZeneca plc seeks a Global Clinical Program Lead to own two immune-reset programs in neuroimmunology, from first-in-patient to pivotal stages. You will define strategy, oversee safety, design trials, and manage regulatory interactions with regulators, investigators and patient partners from Cambridge, MA.

You will guide cross-functional teams across Global Project Lead, Regulatory, Patient Safety and Biostatistics to ensure timely delivery of high-impact studies that recalibrate the immune

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